Regulatory Affairs Expert

4 days ago


Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time
Cancer Diagnostic Innovation Leader

The successful candidate will act as Person Responsible for Regulatory Compliance (PRRC) for MDR/IVDR, ensuring the organisation meets all relevant regulatory standards across global markets. They will provide strategic direction and operational oversight to the regulatory and quality teams, managing compliance with international medical device directives and regulations, including ISO13485 and ISO15189.

This role will play a pivotal part in new product development (NPD), defining regulatory strategies, guiding clinical and analytical validation studies, and liaising with regulatory authorities. The position offers the opportunity to influence the global commercial rollout of a revolutionary cancer diagnostic technology.

Key responsibilities will include experience in IVD medical device product development, adhering to standards such as ISO14971, and in-depth knowledge of global medical device directives, including FDA regulations, MEDDEV guidelines, and ISO standards.

This is an exciting opportunity for an experienced regulatory professional with a passion for innovation in cancer diagnostics to make a significant impact.

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